Status:
COMPLETED
Celiac Plexus Radio-Surgery for Pain Management
Lead Sponsor:
Dr. Yaacov Lawrence
Conditions:
Advanced Cancer
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Many cancer patients, especially those with pancreatic cancer, suffer from severe lower back / upper abdominal pain. This pain is often poorly managed with standard treatments; the doses of painkiller...
Detailed Description
Severe lower back pain radiating anteriorly in a belt-like distribution is characteristic of pancreatic cancer. The pain is thought related to involvement of the celiac nerve plexus, located behind th...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A section 24).
- Patients must have a malignancy that is metastatic or unresectable (for surgical or medical reasons).
- Typical retroperitoneal pain syndrome (pain that radiates from the lower back to the upper abdomen, belt like distribution).
- Uncontrolled pain at recruitment, defined as \>=5 on 11 point BPI scale despite analgesic use.
- Anatomical involvement of the celiac plexus, as defined by at least one of the following:
- Any Pancreatic cancer
- Any other cancer that on imaging demonstrates either: gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels, that typically implies tumor engulfment.
- Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old. The CT simulation performed as part of the protocol will be considered sufficient.
- Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 6 days prior to radiation and renewed at least 6 days following radiation. For trastuzumab emtansine a 14 break prior to, and a 6 day break post-therapy is required. Hormonal treatments (e.g. tamoxifen, androgen ablation, androgen antagonists, aromatase inhibitors), and bone-strengthening agents (e.g. bisphosphonates, anti-RANKL antibody denosumab) may be continued during the radiation treatment, and do not need to be interrupted.
- Willingness to attend 3- and 6- week follow-up visits, and participate in telephone follow-up thereafter.
- Radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Before patient registration, written informed consent must be provided.
Exclusion
- Patients under 18 years of age
- Patients who are well balanced in terms of pain control
- Patients with life expectancy \<8 weeks as defined by the primary oncologist.
- Known serum albumin \<2.4 (does not need to be especially tested if unknown).\*
- Known lymphopenia defined as \<12% of white blood count (does not need to be especially tested if unknown).\*
- Altered mental status (defined as change in brain function from baseline including confusion, drowsiness, delirium, dementia or coma)\*
- Leptomeningeal spread\*
- Current or previous spinal cord compression\*
- Significant comorbidities (this is left to physicians' discretion. Guidance provided below section 8.4. As an example, patients with metastatic cancer, in the context of combined impaired renal and hepatic function are expected to have a poor survival)\*
- Patients with ECOG Performance status 3 or 4\*
- Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy.
- Previous radiotherapy to upper abdomen.
- Conditions associated with increased side effects to radiotherapy (Inflammatory bowel disease, scleroderma for example).
- Patients who have not recovered from the acute adverse events due to prior anti-cancer therapy (however peripheral neuropathy and other chronic side effects of anti-cancer therapy are not exclusion criteria).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Special populations: pregnant women, prisoners, patients with major psychiatric illnesses.
- Unwilling or unable to attend 3-week and 6-week post treatment assessments.
- these factors are all associated with a very poor prognosis. 40 ------ Nb There are criteria that exclude patients from performing the six-minute walk test (see section 29). These patients may nonetheless participate in the protocol and undergo celiac axis radiosurgery.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03323489
Start Date
January 1 2018
End Date
May 1 2022
Last Update
May 12 2022
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
The Mount Sinai Hospital
New York, New York, United States, 10029-6574
2
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
3
Princess Maragret Cancer Center
Toronto, Ontario, Canada, M5G 2C1
4
Sheba Medical Center
Ramat Gan, Israel